Attachment_1-Animal_Husbandry _Animal_Care_and_Technical_Support_Services_PWS_w-Annexes_and_Appendices.pdf

ATTACHMENT 1

PERFORMANCE WORK STATEMENT (PWS)

for

Animal Husbandry Support for the FDA Animal Care and Use Programs (ACUP)

CBER/CDER/CDRH White Oak Consolidated Animal Program (WOC AP) and

Center for Food Safety and Applied Nutrition (CFSAN)

Muirkirk Road Complex – MOD-1 (MRC/MOD-1)

Suzanne.Martella Typewritten Text

FDA-SOL-1153590

Suzanne.Martella Typewritten Text

Suzanne.Martella Typewritten Text

Suzanne.Martella Typewritten Text

Suzanne.Martella Typewritten Text

Suzanne.Martella Typewritten Text

Suzanne.Martella Typewritten Text

Suzanne.Martella Typewritten Text

FDA-SOL-1153590 ATTACHMENT 1

Performance Work Statement (PWS)

Animal Husbandry Support for the FDA Animal Care and Use Programs (ACUP) and CFSAN Research Facility Muirkirk Road Complex – MOD-1 (MRC/MOD-1)

DATE: October 6, 2016

TABLE OF CONTENTS

1. SCOPE……….………………….…………………………………………………………………………………….….…3

1.1. Background……………………………………………………….…………………………………………………….….3

1.2. Objective..……………………………………………………………………………………………………………….…3

1.3. List of Annexes……… …... ………………………………… …….………………………………………………….…4

2. APPLICABLE DOCUMENTS …………… ……………………………………………………………………………….4

3. DEFINITIONS ………………… …………………………………………………………………………………..……….5

4. REQUIREMENTS ………………… ………………………… ……………………………………… ……………..……6

4.1. General Requirements……… …… ………………………… ……………………………………… …………………6

4.2. Specific Requirements……… …… ………………………… …………………………………… ………………..…11

5. DELIVERABLES………………… ………………….……… …………………………………… …………….…….…12

Performance Work Statement (PWS)

Animal Husbandry Support for the FDA Animal Care and Use Programs (ACUP) and CFSAN Research Facility Muirkirk Road Complex – MOD-1 (MRC/MOD-1)

DATE: October 6, 2016

1. SCOPE. Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and otherwise do all things necessary for or incident to provide animal husbandry, animal care and technical support services at two of the Food and Drug Administration’s animal-based research facilities located in Maryland, as described herein.

1.1. Background. The Food and Drug Administration (FDA) is the United States Government regulatory agency responsible for the safety of foods, cosmetics, drugs, biological products, medical devices and radiological products.

1.1.1. Research Centers. The following FDA Centers maintain an on-site animal research program and rely on animal-based research to carry out the FDA’s regulatory mission:

1.1.1.1. The Center for Biological Evaluation and Research (CBER) plans and conducts research related to the development, manufacture, testing and use of both new and old biological products to develop a scientific base for establishing standards designed to ensure the continued safety, purity, potency, and efficacy of biological products.

1.1.1.2. The Center for Drug Evaluation and Research (CDER) conducts research on the safety, efficacy, metabolism and other aspects of mechanism and effects of pharmaceuticals.

1.1.1.3. The Center for Devices and Radiological Health (CDRH) conducts research to observe and measure the individual and additive, short and long range effects of finished device products and the materials contained in these devices such as latex, heavy metals, toxins and radiation.

1.1.1.4. The Center for Food Safety and Applied Nutrition (CFSAN) program focuses on the research and development of standards on the safety, composition, and quality of foods, food additives, color additives, and cosmetics.

1.1.2. Research Facilities.

1.1.2.1. CBER/CDER/CDRH White Oak Consolidated Facility. The animal-based research performed by WOC AP is managed by the CBER Division of Veterinary Services (DVS) and conducted at the Building 10 (64/52/72) Vivarium of the Federal Research Center, 10903 New Hampshire Avenue in Silver Spring MD 20993. This vivarium is an environmentally controlled animal facility that utilizes a single corridor system, houses laboratory animals, primarily mice, rats, hamsters, guinea pigs, rabbits, ferrets, non-human primates, swine, dogs, and frogs. Entrance into the vivarium, support spaces and animal rooms is controlled by an ID card (PIV) card reader system. In addition, the WOC AP also manages eight (8) laboratory Animal Biosafety Level three (ABSL-3) animal room suites capable of housing primarily rodents, ferrets and rabbits in a controlled environment on the fifth floor of Buildings 52/72.

1.1.2.2 CFSAN Research Facility Muirkirk Road Complex. CFSAN’s animal based research is conducted at the FDA Research Facility at the Muirkirk Road Complex – MOD-1 (MRC/MOD-1) in Laurel, Maryland, which houses laboratory animals, primarily rodents, in an environmentally controlled animal facility that utilizes a clean/dirty corridor system. A Biosafety Level 3 (BSL-3)/ Animal Biosafety Level 3 (ABSL-3) Special Pathogens suite is located in the vivarium also. Entrance into the animal facility is through controlled locker rooms. In exceptional circumstances where MOD-1 space is either unavailable or inappropriate for a specific animal study, animal husbandry services will be required in FDA’s MOD-2 facility immediately adjacent to MOD-1. Such studies must be approved by the MOD-2 Director, Office of Research, Center for Veterinary Medicine, and the FDA Contracting Officer (CO).

1.2. Objective. The purpose of this contract is to provide animal husbandry services to FDA’s animal research programs, specifically the provision of quality care to all research animals, sanitation of all animal care and formulation facilities and provision of protocol-specified technical procedures support. Ancillary tasks necessary to accomplish these services are also included (i.e.: quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive employee training program). The need for these services is paramount as the preponderance of FDA’s research mission can only be accomplished through animal research. Animal-based research projects are highly regulated and demand exemplary execution.

This PWS outlines the common requirements applicable to both facilities while attached Annexes further delineate requirements specific to each facility and Center.

1.3. List of Annexes and Appendices. The attached Annexes are included to identify the services required for each facility under this contract. Annexes with their appendices are attached immediately following this PWS.

Annex 1: CBER/CDER/CDRH White Oak Campus Animal Program (WOC AP) Requirements Appendix 1: CBER/CDER/CDRH WOC AP Government Furnished Property (GFP) Appendix 2: CBER/CDER/CDRH WOC AP Quality Assurance Surveillance Plan (QASP)

Annex 2: CFSAN Muirkirk Road Complex MOD-1 (MRC/MOD-1) Requirements

Appendix 1: CFSAN MRC/MOD-1 Government Furnished Property (GFP) Appendix 2: CFSAN MRC/MOD-1 Quality Assurance Surveillance Plan (QASP)

2. APPLICABLE DOCUMENTS. To ensure the successful accomplishments of FDA’s research mission, animal care services, at a minimum, shall comply with regulations and guidelines below, as well as any amendments or revisions thereto.

2.1. Federal Regulations, Policies and Procedures.

a. Animal Welfare Act as Amended (7 USC, 2131-2159).

https://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.pdf

b. Animal Welfare Act Regulations (Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare) (2013).

https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Blue%20Book%20- %202013%20-%20FINAL.pdf

c. Guide for the Care and Use of Laboratory Animals, Eighth Edition, Institute of Laboratory Animal Resources (ILAR), Division of Earth and Life Sciences, National Research Council, 2011.

http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf

d. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, 2015.

http://grants.nih.gov/grants/olaw/references/phspol.htm

e. American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, 2013 https://www.avma.org/KB/Policies/Documents/euthanasia.pdf

f. Occupational Safety and Health Administration Regulations (Standards – 29 CFR) including the Hazard Communication Standard (OSHA Standards, 29 CFR 1910.1200) and the Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450).

http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106

g. Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 2007); Biological Safety Level-2 (BSL-2) Manual and Biological Safety Level-3 (BSL-3) Manual.

http://www.cdc.gov/biosafety/publications/bmbl5/index.htm

h. Good Laboratory Practice Regulations (21 CFR 58).

http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html

i. Environmental Protection Agency (EPA) Resource Conservation and Recovery Act Regulations.

https://www.epa.gov/rcra/resource-conservation-and-recovery-act-rcra-regulations https://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.pdf https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Blue%20Book%20-%202013%20-%20FINAL.pdf https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Blue%20Book%20-%202013%20-%20FINAL.pdf http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf http://grants.nih.gov/grants/olaw/references/phspol.htm https://www.avma.org/KB/Policies/Documents/euthanasia.pdf http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106 http://www.cdc.gov/biosafety/publications/bmbl5/index.htm http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html https://www.epa.gov/rcra/resource-conservation-and-recovery-act-rcra-regulations

2.2. Availability of Federal Regulations, Policies and Procedures. Unless otherwise indicated, copies of the aforementioned documents are available for free distribution online.

2.3. Center-Specific Policies and Procedures. The contractor will be required to comply with Center-specific manuals outlining policies and procedures. These manuals may include any or all of the following:

a. Center-specific Staff Safety Manual.

b. Center-specific Occupant Emergency Plan.

c. Center-specific Standard Operating Procedures (SOPs).

2.4. Availability of Center-Specific Policies and Procedures. Center-specific documents can be accessed at each facility’s on-site library.

3. DEFINITIONS. As used throughout this Performance Work Statement (PWS), the following terms shall have the meaning set forth below and specified as applicable to this contract.

3.1. AAALAC Accreditation. AAALAC, International is a private, nonprofit organization that evaluates institutions that use animals in research, teaching, or testing and awards accreditation to those that meet or exceed the standards for humane treatment of animals outlined in the Guide for the Care and Use of Laboratory Animals (National Research Council, 2011), the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Federation of Animal Science Societies, 2010), and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purpose (Council of Europe, ETS 123).

3.2. American Association for Laboratory Animal Science (AALAS). AALAS is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals. The association provides educational materials to laboratory animal care professionals and researchers, administers certification programs for laboratory animal technicians and managers, publishes scholarly journals, supports laboratory animal science research, and serves as the premier forum for the exchange of information and expertise in the care and use of laboratory animals.

3.3. Center for Tobacco Products (CTP). CTP, a part of the FDA, oversees the implementation of the Family Smoking Prevention and Tobacco Control Act.

3.4. Contracting Officer (CO). A Government employee with the authority to enter into and administer contracts and make determinations and findings with respect thereto, or with part of such authority.

3.5. Contract Specialist (CS). A Government employee, acting as a representative of and operating under the authority of the CO, who performs contract-related administration activities.

3.6. Contracting Officer’s Representative (COR). A Government employee who provides technical clarification and guidance with respect to the PWS and serves as the technical liaison between the Contractor and the CO.

3.7. Contractor. Refers to both the Prime Contractor and all Subcontractors. The Prime Contractor shall be responsible for ensuring that its Subcontractors comply with the requirements of this PWS.

3.8. Cooperative Research and Development Agreement (CRADA). A CRADA is an agreement between one or more FDA laboratories and one or more non-Federal parties under which the FDA laboratory provides personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts.

The CRADA partner contributes all of the above and funding to the project.

3.9. Good Laboratory Practice (GLP). A set of regulations that applies to animal and non-animal research and safety studies funded or reviewed by the FDA. The regulations are a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests. (21CFR, Part 58;

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58&showFR=1).

3.10. Government Furnished Property (GFP). All Government facilities, property, and supplies provided to the Contractor to be used by the Contractor in carrying out responsibilities set forth in this PWS. Ownership of GFP remains that of the Government at all times (unless and until consumed or expended in the normal course of business) and all GFP shall be returned and/or accounted for upon completion of the contract.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58&showFR=1

3.11. Occupational Safety and Health Administration (OSHA). As part of the U.S. Department of Labor, OSHA sets and enforces standards to assure safe and healthful working conditions for working men and women.

OSHA Standards, 29 CFR 1910 and 1925:

http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=0

3.12. Organization for Economic Cooperation and Development (OECD) Test Guidelines. A collection of the most relevant internationally agreed test methods used by government, industry, and independent laboratories to determine the safety of chemicals and chemical preparations (http://www.oecd.org/env/ehs/testing/oecdguidelinesforthetestingofchemicals.htm).

3.13. Principal Investigator (PI). The PI is the ultimate customer; the lead scientist with ultimate responsibility for a research protocol. The terms “PI” and “study director” (GLP term) are used interchangeably.

3.14. Protocol. Protocols are experimental designs written by Principal Investigators, approved through management and performed at the centers. The terms “protocol” and “study” are used interchangeably.

3.15. Quality Assurance Surveillance Plan (QASP). The plan developed specifically for the PWS, to assure compliance with the requirements. This should not be confused with the Contractor’s internal Quality Assurance (QA) required by GLP guidelines. The QASPs for each Center’s requirements are attached at Appendix 2 to the Center-specific Annex.

3.16. Quality Control Plan (QCP). A document that includes all measures the Contractor will take to ensure that the quality of an end item or service meets the contract requirements regarding timeliness, accuracy, appearance, completeness, consistency, and conformity to appropriate standards and/or specifications. It includes, but is not limited to a written set of self-inspection checklists developed by the Contractor that comprehensively detect variations from the contract requirements; recording of work data; trend analysis; feedback and control systems for correcting deficiencies; and the necessary documentation to record findings.

3.17. Standard Operating Procedures (SOPs). A formally documented specific set of procedures to be followed in carrying out a given operation or in a given situation.

3.18. Study. Studies are experimental designs written by PIs, approved through management and performed at each Center. The terms “protocol” and “study” are used interchangeably.

4. REQUIREMENTS.

4.1. General Requirements. See attached Center-specific Annexes.

4.1.1. Hours of Operation. See attached Center-specific Annex.

4.1.2. Observance of Federal Holidays & Other Government Closings. The Federal Holidays are as below unless otherwise identified by the Contracting Officer (CO):

New Year’s Day January 1st Martin Luther King Day Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Independence Day July 4th Labor Day First Monday in Sept.

Columbus Day Second Monday in Oct.

Veteran’s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

In the event there is a Holiday or administrative leave announced other than those recognized Federal Holidays, the Contractor shall provide sufficient staff to provide essential services including scheduled protocol-specific tasks as identified in the applicable Center-specific Annex.

The Contractor’s management and professional personnel shall be on-site during core hours, Mon-Fri. If not on-site, they or qualified designees shall be available by telephone within 30 minutes for any emergency which may arise in the animal facilities. Additionally, the contractor shall provide their contract management staff with designated cell http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=0 http://www.oecd.org/env/ehs/testing/oecdguidelinesforthetestingofchemicals.htm phones (or other communication devices) to permit telephone access during emergencies that arise during non-core hours. If there is an emergency, the COR will notify the Contractor Project Manager verbally, and within 24 hours, will provide a written authorization to cover additional work requirements. As with all contracts, only the CO is authorized to issue change orders or any directive that creates a cost implication.

4.1.3. Place of Performance. As outlined in each Center-specific Annex.

4.1.4. Physical Security. The Contractor shall be responsible for safeguarding all Government equipment, information and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

4.1.5. Key and Access Card Control. The Contractor shall insure that keys and/or electronic access cards issued to the Contractor are not lost or misplaced and are not used by unauthorized persons. Only designated Government personnel shall duplicate keys issued to the Contractor. The Government will provide identification badges and electronic access cards to be used by all Contractor personnel. The Contractor shall immediately report the occurrence of a lost key or electronic access card to the COR. Contract employees shall not grant access to any work areas to persons other than Contract employees engaged in the performance of assigned work in those areas.

4.1.6. Standard Operating Procedures. All work associated with animal husbandry, animal care and technical support services shall be performed in strict compliance with the reviewed SOPs. SOPs for areas, operations, and procedures directly within the Contractor's responsibility shall be written and maintained by the Contractor to reflect the current procedures used by their firm. The Contractor shall enforce SOPs to ensure that procedures are conducted as specified. All SOPs shall be delivered to the COR, the Director of Veterinary Services, and, if applicable, the Center’s IACUC Chairman for review before finalizing and placing into service.

Review of SOPs by the COR, the Director of Veterinary Services, or the Center’s IACUC prior to finalizing and placing into service is not intended as, and shall not be construed as, approval or any assumption of responsibility or liability by the Government. SOPs should be reviewed and revised as needed but not greater than every 2 years.

New or revised SOPs shall be distributed to the applicable COR within 15 days of request.

During periods of Contractor transition, the new Contractor shall perform services under guidelines of in-place SOPs at the time duties are assumed and until such time that the SOPs are revised, if necessary.

4.1.7. Quality Control (QC). The Contractor shall provide all quality control for services performed under this contract, ensuring that the results produced are complete and accurate. The Quality Control program shall be designed to ensure that the Contractor is providing animal husbandry, animal care and technical support services in compliance with established SOPs, approved protocols, and applicable GLP requirements. The Contractor shall write, implement, and enforce a Quality Control Plan (QCP), which shall be reviewed and approved by the CO.

Submission of the QCP is detailed in Section 5, DELIVERABLES. The QCP shall be designed to monitor all functions in animal husbandry and technical support services to confirm that results are complete, accurate, and in compliance with established SOPs, approved protocols, and applicable GLP requirements. Quality control functions under this contract shall include but not be limited to:

a) Verifying that all study activity schedules are accurate and comply with the approved protocol and that all study activity schedules are provided to the Study Director, the COR, and the NCTR QAU. All study activity schedules should be retained in the study file and submitted to the NCTR archives at the close of a study.

b) Ensuring that all formulated products (e.g., dosed feed, dosed water, solutions, skin creams, etc.) are accurate and comply with established SOPs and the approved protocol. Ensure that all containers are labeled appropriately (21 CFR 58 Subpart F). Ensure that all accountability documentation is complete, accurate, and retained accordingly.

c) Providing GLP training and maintain a current summary of training and experience and job description for each staff member.

d) Conducting at least monthly inspections of all animal care facilities for compliance with the contract, established SOPs, and approved protocols. Items inspected shall include but not be limited to performance in compliance with SOPs, housekeeping and sanitation status of physical plant, animal housing conditions, appearance of animals, up-to-date calibration of equipment, adherence to preventive maintenance schedules, expiration dates of chemicals, feed, bedding, etc., proper use of required PPE, correct recordkeeping (documents, reports, logbooks, etc.), adherence to safety rules, etc.

4.1.8. Personnel. The Contractor shall provide the necessary professional, technical, and administrative personnel with the required qualifications needed to provide the FDA with high-quality animal husbandry, animal care and technical support services. The management and technical positions presented in each requirement reflect the required organizational structure for project management, animal care and technical procedures. Quality control, training, occupational safety and health, inventory, and equipment maintenance support tasks are currently positioned at or above the technical specialist level. However, the Contractor may propose alternative labor mixes that they believe to be more efficient.

Please be advised that the Government places a high priority on the technical workforce (foremen, technicians, assistant technicians, and animal caretakers) being AALAS certified at the Assistant Laboratory Animal Technician (ALAT) level or higher. At least 85% of the technical workforce is required to be AALAS certified at all times. In addition, the importance of providing a sufficient number of technicians who are highly trained, skilled, competent, and consistent in performing the technical procedures required for research animal protocols at WOC AP is of paramount importance. Management personnel shall have appropriate education and degrees for the position occupied and should have experience in areas of animal toxicology research, diet preparation/formulations, laboratory animal science, or related disciplines. Specifically, key personnel shall be knowledgeable of the Guide for the Care and Use of Laboratory Animals, Public Health Service Policy on Humane Care and Use of Laboratory Animals, Animal Welfare Act Regulations, and National Toxicology Program Specifications.

The qualifications required for personnel employed to provide services on this contract are described for each position level listed in the individual Center-specific Annexes. Except where specified, these position levels should not be considered as the absolute requirement, type, or number of positions required for the duration of the contract. The Contractor should constantly seek to provide an organizational structure/labor mix which will operate the most efficiently and effectively.

Qualifications of proposed staff (key personnel) are subject to review by the COR and approval by the CO.

4.1.9. Employee Training. The Contractor shall provide for all training to animal care and technical procedures support personnel as appropriate to their assigned duties which may include training in biology, husbandry, sanitation, handling and restraint, nutrition, zoonoses, personal protective equipment, safety, hazardous materials, and any other situation for which the staff may need training. A Training Coordinator shall be required to ensure standardization of the procedures and training processes. The Training Coordinator shall develop a standardized system to ensure that a pool of a minimum of 70% of the technical procedure staff is proficient on each protocol required technical procedure at any one time. Technicians working in any area shall receive the necessary training needed to perform their duties effectively and efficiently in that area and with maximum safety protection. The program shall include Occupational Safety and Health training to ensure maximum safety of the employee and instruction in GLP (including appropriate documentation, data entry concepts) to ensure compliance with these regulations. In addition, the Contractor will encourage, foster, and support the attainment of AALAS certification of all eligible contract personnel. The Contractor shall determine successful completion criteria for each type of training and include in the quarterly training report the date of training, type of training, the number of employees attending training, and the number of employees successfully completing training. The Contractor shall maintain plans/records of training for each employee separate from other personnel records and shall certify the competency of each employee for each procedure performed by the employee.

It is the sole responsibility of the Contractor to develop a comprehensive Employee Training Plan which will provide the contract staff with the knowledge and skills necessary to ensure quality performance of their duties or task assignments in compliance with applicable laws, regulations, and guidelines. Therefore, the Government will assume no liability or responsibility for death, bodily injury, property damage or any other adverse condition resulting from the violation of applicable laws or regulations or insufficient training of staff. Submission of the Employee Training Plan is detailed in the RFP in Section 5 of this PWS, DELIVERABLES.

4.1.10. Occupational Safety and Health. The Contractor shall be responsible for the development, administration, and compliance of the contractor Occupational Safety and Health Program. All services and/or work performed under this contract shall, at a minimum, be performed in accordance with Federal, State, Local, FDA and NCTR safety policies, regulations, and safety guidelines as they may apply, including, but not limited to OSHA and the Environmental Protection Agency (EPA). Compliance with Federal, State and Local Occupational Safety and Health Acts and other applicable laws and regulations are the sole and exclusive obligation of the Contractor.

Therefore, the Contractor is totally liable for, and the Government will assume no liability or responsibility for death, bodily injury, property damage or any other adverse condition resulting from the violation of applicable laws, regulations, SOPs, or safety precautions caused in whole or in part by the Contractor or the Contractor’s employees’ negligence or willful acts or omissions committed in the performance of this contract.

The Contractor shall provide a finalized version of the Occupational Health and Safety Plan (OSHP). The FDA will review and provide comments within 15 calendar days of receipt. The Contractor shall incorporate revisions and submit a revised Final OSHP to the Contracting Officer no later than 15 days after receipt of the Government’s review. The OSHP shall contain, but will not be limited to, the development and implementation of OSHP SOPs and policies, personal protective equipment (PPE) requirements, and OSH training. A component of the plan shall also be the appointment of a Contract Safety Liaison to the ESHC as a conduit for disseminating safety, health, and environment information.

The Contractor shall monitor and enforce the OSHP, report SOP deviations, and direct staff training to ensure safe work practices and equipment operation throughout the Contractor assigned facilities. The OSHP and OSH training should include animal care procedures, special biological techniques, handling of hazardous compounds, and other procedures that may be required in the operation of a laboratory animal facility.

For safety reasons, all personnel shall be able to read, understand, and communicate in English.

4.1.11. Medical Examinations. The Contractor shall require all personnel who will be working in FDA facilities on this contract to submit to the following medical examinations or procedures before being allowed access into those animal rooms or laboratories. The Contractor shall not knowingly employ any person who is identified as a potential threat to the health, safety, security or general well-being or mission of the FDA, or endangers themselves or other persons. The Contractor shall verify in writing to the COR that personnel have received a baseline physical examination and are medically fit for work prior to reporting to work. The baseline physical examination shall include the following procedures:

1) Medical history review with emphasis on:

a) Status of tetanus immunization

b) Status of allergies to fur, animals, and latex

2) Audiogram

3) 3) Laboratory tests

a) Chem-26 analysis

b) Complete blood count

c) Urine analysis

d) Test for fecal parasites

4) Pulmonary function test, if deemed medically necessary (required annually if using a respirator), to include:

a) Forced Vital Capacity (FVC)

b) Forced Expiratory Volume @ I second (FEV-1)

c) Percentage of air expired per person (FEVI/FVC)

5) TB screen (purified protein derivative (PPD) skin test)

6) Measles vaccination or adequate measles titer

7) Tetanus vaccination or booster

8) Polio (verification of immunity), annual Influenza, hepatitis B, smallpox, and HIV/SIV testing are all required for contactors working with primates.

9) Vision screen

10) Vital signs (blood pressure, temperature and pulse)

11) Chest X-ray – if deemed necessary

12) Electrocardiogram (EKG; for employees over age 40 years)

13) Respirator fit test – is required for N95 use.

14) Other tests as indicated from individual history.

The Contractor's employees shall have annual physical examinations. The Contractor shall verify in writing that personnel have received an annual physical examination and remain medically fit for work. The periodic physical exams, and annual medical evaluations, including pre-placement or pre-assignment evaluations, along with associated medical record-keeping annual physical examination shall include the following procedures:

1) Interval medical history review related to Occupational Health Hazards with emphasis on:

a) Status of tetanus and other required immunizations

b) Allergies to fur, animals, and latex

2) Vital signs (blood pressure, temperature and pulse)

3) Vision screen

4) TB screen (PPD test)

5) Respiratory Fitness Test

6) Respirator Fit Test, as needed

Medical examinations or procedures will be at the Contractor's cost.

4.1.12. Data Management. The Contractor's animal care staff shall be familiar with FDA’s data systems

(automated and manual) associated with animal census, purchase requests, etc., and be able to accomplish all data entry procedures accurately. The Center will train the appropriate contractor staff in all aspects of the data operating systems they shall be required to use.

The Contractor's staff shall enter the required data into the computer or manual systems and maintain other required records. These records include, but are not limited to, approved protocols and amendments, SOPs approved by the Contracting Officer’s Representative(s) or Safety Officers, logs for each room with dates for changing and sanitizing cages, racks, pans, feeders, water bottles, environmental checks, animal observations and animal or supply delivery/packing receipts, as required. All entries shall be initialed and dated by the staff person performing the procedures. All original paperwork shall be provided to the Principal Investigator/Study Director immediately after the study is complete, as applicable, or to the COR or designee for filing; if not originals, copies will be provided to the COR or designee. All data are considered privileged information and cannot be shared or distributed by the Contractor without the Government’s permission. The contract staff shall recognize computer system malfunctions and report the malfunctions to the Contracting Officer’s Representative(s) in a timely manner and then proceed with manual record keeping. The animal care staff shall enter the manually collected data into the computer system when it becomes available. Contractor employees will abide by security requirements established by the Government for access and use of computers in federal facilities at all times.

4.1.13. Contractor Furnished Materials. See attached Center-specific Annex.

4.1.14. Government Furnished Property. See attached Center-specific Annex.

4.1.15. Inventory Control. The Contractor shall maintain an accurate inventory of government furnished supplies, materials, and equipment used to perform/support the tasks required under this contract, to include items that are stored and items that are in use. This shall include participation in the government inventory process as a designated property custodian officer (PCO). Such items include cages (e.g., plastic, stainless steel, metabolism, ventilated, etc.) and accessories, microisolator lids, racks, water bottles, sipper tubes, water bottle cases, feeders, animal feed, animal feed bins, bedding, chemicals, cleaning/sanitizing equipment, enrichment items, veterinary supplies and equipment, tools for equipment repair, electronic balances, mechanical balances, animal restraint devices, transport vehicles (forklifts, golf carts), office furniture, copy machines, computers, monitors, printers, etc.

Government Furnished Property will be listed in an Appendix to the Center-specific Annex.

On the first day of the contract, the Contractor and a Government representative(s) shall conduct a joint inventory of all government furnished equipment. The Contractor and Government representative(s) shall determine the working order and condition of all equipment. The Government will replace missing items(s) and repair all item(s) not in working order, or the Contracting Officer will direct the Contractor to replace/repair these item(s) for which the Contractor will be reimbursed. The Contractor and the Government representative(s) shall agree as to the working order of the equipment. If the Contractor does not participate in the inventory, the Contractor shall accept as accurate the listing and stated condition of equipment provided by the Government. Any disagreement with the Government's determination as to the working order of the equipment shall be treated as a dispute pursuant to the "Disputes" clause.

The Contractor shall submit requests for additional or replacement of Government furnished equipment to the COR, who will then take the request to the CO if appropriate.

Thirty (30) days prior to the expiration date of the contract, the Contractor and a Government representative(s) shall conduct a joint inventory of equipment. The Contractor shall be liable for loss or damage to Government furnished property beyond fair wear and tear in accordance with the FAR Government Furnished Property clause. Any disagreement with such determinations shall be treated as a dispute pursuant to the "Disputes" clause.

4.1.16. Estimated Workload. See attached Center-specific Annex.

4.2. Specific Requirements. See attached Center-specific Annex.

5. DELIVERABLES. The following are required deliverables common to both Facilities/Programs. Other reporting/deliverables are outlined further in Center-specific Annexes. Deliverables shall be submitted electronically, in Microsoft Word, PDF, or Excel compatible format, and are subject to the inspection and acceptance by the COR (or as otherwise applicable). Other special reports may be requested on an as needed basis.

Schedule of Deliverables

Ref. Scheduled Item Submit To Due Date

5.1. Transition Plan Submit w/Proposal Submit as part of Technical Proposal.

5.2. Occupational Safety and Health Plan

• Submit w/Proposal.

• Final to CO.

• Updates to CO.

• Draft - Submit with Technical Proposal.

• Final - Submit within 15 days after the award date of the contract.

• Reviewed (and updated if required) annually.

5.3. Employee Training Plan

• Submit w/Proposal.

• Final to CO.

• Updates to CO.

• Draft - Submit with Technical Proposal.

• Final - Submit within 15 days after contract award.

• The training plan shall be reviewed annually and updated if required.

5.4. Quality Control Plan

• Submit w/Proposal.

• Final to CO.

• Updates to CO.

• Draft - Submit with Technical Proposal.

• Final - Submit NLT than 30 days after beginning of contract performance.

• Update annually thereafter, w/in 30 days of exercise of Option Period

5.5. Security Clearance Forms COR Ten calendar days prior to

commencement of work.

5.6. Insurance Certificate CS/CO Prior to commencement of work.

5.7. Verification of Baseline Medical Exams COR, copy CS/CO Prior to commencement of work.

5.8. Verification of Annual Medical Exams COR, copy CS/CO Once a year.

5.9. GFP Inventory Report COR

First day of contract, 30 days prior to contract expiration, monthly, and quarterly

5.10. New or Revised SOPs COR As required.

5.11. Daily Report COR COC daily.

5.12. Monthly Report COR NLT the 10th of each month for the

preceding month.

5.13. Final Report COR, copy CS/CO NLT 30 calendar days after contract end.

5.14. Phase-out Plan CS/CO NLT 30 calendar days prior to the end of the contract.

5.1. Transition Plan. As detailed in the RFP, submit a Contractor Transition Plan that integrates current personnel into management strategy, new personnel in with the systems and processes already in place and ensure seamless changeover, especially in terms of ongoing projects and animal welfare.

5.2. Occupational Safety and Health Plan. A comprehensive plan outlining the Contractor’s approach for ensuring compliance with contract requirements. A draft OSHP is to be submitted as part of the Contractor’s Technical Proposal. The final OSHP is due within 15 days after contract award. Plan shall be reviewed annually and updated as required.

5.3. Quality Control Plan. As detailed in this PWS, a draft QCP is to be submitted as part of the Contractor’s Technical Proposal. The final QCP is due no later than thirty (30) days after contract award. An updated QCP is due annually, no later than 30 days after the beginning of each option year.

5.4. Employee Training Plan. As detailed in this PWS, a draft plan is to be submitted as part of the Contractor’s Technical Proposal. The final plan is due within 15 days after contract award. The Training Plan will be reviewed (and updated, if required) annually.

5.5. Security Clearance Forms. Contractor shall submit completed security forms for all on-site contract employees and subcontractors ten (10) calendar days prior to commencing work under this contract.

5.6. Insurance Certificate. As outlined in the RFP and as per the applicable FAR Clause, Contractor shall provide a certificate or written statement of insurance prior to commencing work under this contract.

5.7. Verification of Contractor Personnel Baseline Medical Exam. The Contractor shall verify in writing that personnel have received a baseline physical examination and are medically fit for work prior to reporting to work. The baseline physical examination requirements are outlined elsewhere in this PWS.

5.8. Verification of Contractor Personnel Annual Medical Exam. The Contractor shall verify in writing that personnel have received an annual physical examination and remain medically fit for work. The annual physical examination requirements are outlined elsewhere in this PWS.

5.9. GFP Inventory Reports. As detailed in this PWS, the Contractor and a Government representative(s) shall conduct a joint inventory of Government Furnished Property (GFP) on the first day of the contract and thirty (30) days prior to the expiration date of the contract. This report shall include, as a minimum, the following information:

(a) Description of each GFP item to include model number, serial number, FDA property decal number, quantity and location.

(b) Any transfers of GFP made during the reporting period.

(c) Any maintenance performed on GFP item during the reporting period.

Additionally, an inventory of all GFP items in use or in storage shall be conducted on a monthly and quarterly basis.

This report shall include the same information as required in the contract initial GFP and Final reports.

5.10. New or Revised SOPs. Report of any newly created, revised, or deleted SOPs during the previous month and a certification that SOPs are in place for all procedures, tasks, and duties required of the Contactor.

5.11. Daily Report. A summary of daily equipment function such as house medical equipment, wet cages, cage wash equipment operations, service requests submitted, previous service requests still pending, contract staffing, staff husbandry and care coverage, significant animal health and welfare findings, animal holding HVAC parameters animal micro-environmental parameters such as frog tank water quality test results and BSL 3 care, observations and equipment function. Deviations from SOP and routine animal care and husbandry shall be reported daily by email.

In the Daily Report, also describe any SOP deviations by employees, the effects of those deviations, personnel action taken, and corrective procedures to ensure prevention of future deviations.

5.12. Monthly Report. A summary of the work accomplished during the previous month shall quantitatively address the work performed for all contract tasks including animal care services and/or technical procedure support performed for each experiment; provided for nonhuman primates and other species if applicable; employee training program functions; quality control program functions; occupational health and safety program functions; and equipment maintenance support activities. Also include personnel actions, travel, and any issues or problems that occurred during the month and/or need attention/rectification. A list of current employees by position to include assigned duties and change schedules.

Note: Included in the Monthly Report, also describe any SOP deviations by employees, the effects of those deviations, personnel action taken, and corrective procedures to ensure prevention of future deviations

5.13. Final Report. This final report documents and summarizes the work accomplished during the entire contract period. The report shall include tables, graphs, diagrams, photographs, drawings, etc. as necessary and in sufficient detail to comprehensively explain the results achieved under this contract.

5.14. Phase-Out Plan. Submit no later than 30 calendar days prior to the end of the contract.

End of PWS

ANNEX 1 to ATTACHMENT 1

FDA-SOL-1153590 PWS ANNEX 1

Animal Husbandry Support for the FDA Animal Care and Use Programs (ACUP)

CBER/CDER/CDRH White Oak Consolidated Animal Program (WOC AP) October 6, 2016

1. SCOPE. Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and otherwise do all things necessary for or incident to provide animal husbandry and technical procedures support services equivalent to or exceeding the accepted standards and practices of the Laboratory Animal Care industry to White Oak Consolidated Animal Program as described herein.

1.1. Background. The White Oak Consolidated Animal Program (WOC AP) is located at the White Oak Campus of the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland. WOC AP is comprised of three

(3) Centers that use animal-based research to carry out the FDA’s mission:

1.1.1 The Center for Biological Evaluation and Research (CBER) plans and conducts research related to the development, manufacture, testing and use of both new and old biological products to develop a scientific base for establishing standards designed to ensure the continued safety, purity, potency, and efficacy of biological products.

1.1.2 The Center for Drug Evaluation and Research (CDER) conducts research on the safety, efficacy, metabolism and other aspects of mechanism and effects of pharmaceuticals.

1.1.3 The Center for Devices and Radiological Health (CDRH) conducts research to observe and measure the individual and additive, short and long range effects of finished device products and the materials contained in these devices such as latex, heavy metals, toxins and radiation.

The animal-based research performed by WOC AP is managed by the CBER Division of Veterinary Services (DVS) and conducted at the Building 10 (64/52/72) Vivarium of the Federal Research Center, 10903 New Hampshire Avenue in Silver Spring MD 20993. This vivarium is an environmentally controlled animal facility that utilizes a single corridor system, houses laboratory animals, primarily mice, rats, hamsters, guinea pigs, rabbits, ferrets, non-human primates, swine, dogs, and frogs. Entrance into the vivarium, support spaces and animal rooms is controlled by an ID card (PIV) card reader system. In addition, the WOC AP also manages eight (8) laboratory Animal Biosafety Level three (ABSL-3) animal room suites capable of housing primarily rodents, ferrets and rabbits in a controlled environment on the fifth floor of Buildings 52/72.

1.2. Objective. The purpose of this contract is to provide animal husbandry services to WOC AP’s animal research program specifically the provision of quality care to all research animals, sanitation of all animal care and formulation facilities and provision of protocol-specified technical procedures support. Ancillary tasks necessary to accomplish these services are also included (i.e.: quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive employee training program). The need for these services is paramount as the preponderance of WOC AP’s research mission can only be accomplished through animal research. Animal-based research projects are highly regulated and demand exemplary execution.

1.3. List of Appendices. The attached appendices are included to assist in providing a complete record of the services that have been previously provided, as well as to outline the expected level of services required under this contract. Appendices are attached immediately following this Annex.

Appendix 1: CBER/CDER/CDRH WOC AP Government Furnished Property (GFP) Appendix 2: CBER/CDER/CDRH WOC AP Quality Assurance Surveillance Plan (QASP)

2. APPLICABLE DOCUMENTS. To ensure the successful accomplishments of WOC AP’s research mission, animal care services, at a minimum, shall comply with the following regulations and guidelines, as well as any amendments or revisions thereto.

2.1. Federal Regulations, Policies and Procedures. Federal regulations have been identified in the main PWS and apply to these Centers.

2.2. Availability of Federal Regulations, Policies and Procedures. Unless otherwise indicated, copies of the aforementioned documents are available for free distribution online.

2.3. Center-Specific Policies and Procedures.

a. WOC AP Environment, Safety and Health Manual.

b. WOC AP Occupant Emergency Plan.

c. WOC AP Animal Care Standard Operating Procedures (SOPs).

d. WOC AP BSL2 and BSL3 Manuals.

2.4. Availability of Center-Specific Policies and Procedures. WOC AP specific documents can be accessed at the facility’s on-site library.

3. DEFINITIONS. As outlined in the main PWS.

4. REQUIREMENTS.

4.1. General Requirements. The Contractor shall perform the requirements of this PWS in accordance with the following General Requirements:

4.1.1. Hours of Operation.